Orthocell sets stage for commercialisation progress with CelGro®, Striate+ and Ortho-ATI® after busy June quarter

Orthocell Ltd has reflected on recent achievements in its latest quarterly report, detailing what it describes as “a period of significant clinical and commercial growth” for the company. The ASX-lister recorded $1.81 million in net operating cash flows as it progressed work across its CelGro® and Striate+ product portfolios over the June quarter, with key highlights including a nerve regeneration trial and work towards US market entry. Looking ahead, Orthocell is on track to provide a final data readout for a rotator cuff study using the company’s Ortho-ATI® cell therapy in the current quarter. By the end of the quarter, Orthocell had $16.32 million in the bank to support its progress towards regulatory approvals and the company’s commercialisation strategy. Looking forward to “very exciting period” Orthocell managing director Paul Anderson said: “The company has had another great quarter, progressing the US and Australian market entry of Striate+ dental and the US regulatory program for our CelGro® nerve regeneration device. “I am excited by the potential of our Australian invented and manufactured products, and look forward to what is shaping up to be a very exciting period for the company.” CelGro® During the June quarter, Orthocell released data from a nerve regeneration trial that used its CelGro® platform medical device, which augments surgical repair of soft and bone tissue. The regenerative medicine company conducted the first interim data readout of all patients in the CelGro® clinical trial 12 months after the study concluded. Promisingly, 25 out of 33, or 75.8%, of all nerve repairs that took place during the study resulted in functional recovery. Now it has the 12-month data at hand, Orthocell is preparing a submission for the Food and Drug Administration (FDA) in a bid to prepare CelGro for the regulatory approval pathway. In addition, the ASX-lister is in talks with US insurance companies and key opinion leaders to finalise its commercialisation approach. Orthocell has also engaged Experien Group as the company’s US regulatory advisers to evaluate opportunities for expedited approval of CelGro® for nerve regeneration. Market opportunities for Orthocell's CelGro® technology. Striate+ During the June quarter, Orthocell also progressed preparations to bring its Striate+ dental product to the US market. In January this year, the ASX-lister received FDA 510(k) clearance to market and supply Striate+ to dental bone and tissue repairs in the US dental market, which is estimated to be worth US$500 million per annum. As it works towards Striate+’s market entry, Orthocell was incorporated as a US company, set up a US warehouse and logistics solution, prepared to launch with two dental groups, established influencer and key opinion leader accounts and worked on a digital marketing campaign. Meanwhile, in Australia, Striate+ was included on the Australian Prostheses List, meaning dental practitioners can now receive reimbursement from private insurers. Owing to this, Orthocell has also spent time preparing to launch in the Western Australian market, establishing key opinion leader accounts, engaging public and teaching hospitals, private hospitals and corporatised dental practices and evaluating potential distributors. After the June quarter ended, the company engaged Samson Medical Technologies as the exclusive Australian of Striate+ for bone and soft tissue repair. Finally, in the UK and EU, the ongoing pandemic has hampered dental practitioners from treating patients. As a result, Orthocell is using this time to focus on clinician advocacy and digital marketing, engaging key opinion leaders to create video content on Striate+. Ortho-ATI® and intellectual property Currently, Orthocell is conducting two clinical trials with its Ortho-ATI® novel cell therapy, developed to treat chronic degenerative tendon injuries. One of these, focused on the rotator cuff, is fully recruited and on track to provide a final data readout in the current quarter. This will be the world’s first randomised, active-controlled clinical trial of a tendon regeneration cell therapy and represents a significant milestone for the company as it works towards US approval and commercialisation. Meanwhile, Orthocell’s tennis elbow study is 80% recruited and should hit full recruitment before year’s end. During the June quarter, Orthocell also secured patents in China, New Zealand and Hong Kong covering its CelGro® medical device platform for soft tissue regeneration applications.